Laser imaging device makes no-cut biopsies possible

Tara Brosnick, a medical student at Rutgers University, performs an optical biopsy on a patient’s face using the VivaScope 3000. Brett Johnson/Brett Johnson of One Media Place in New York.

Allison Herschell is just 26 years old but has already undergone multiple biopsies to check for skin cancer, each one carving off a small piece of her flesh. Thankfully, every test has come back negative, but the procedures take their toll: the cut from the scalpel, two weeks of nervous waiting for results, and another scar.

“It’s really not a fun time,” said Herschell, who is fair-skinned and has several moles. “They just shave this area of your skin off and then you have this open wound until it scars up and heals, and they’re not in cosmetically nice places on my body.”

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But Herschell no longer dreads her trips to the dermatologist, thanks to the company she joined two years ago, Caliber Imaging and Diagnostics, which makes advanced laser imaging devices that enable doctors to perform biopsies without cutting into skin and to determine immediately if the patient has cancer.

Caliber’s machines use low-power laser beams that shine through the skin and reflect off subsurface tissue, illuminating the skin cells in question. With the company’s newest device, the VivaScope 3000, the patient experience is similar to that of having an ultrasound. The doctor — or even a technician — rolls the head of a hand-held wand over the skin, capturing still images which are then projected on a monitor.

A high-resolution image from a laser scan mimics what a pathologist would see under a microscope. Brett Johnson/Brett Johnson of One Media Place in New York.

Instead of a grainy sonogram, however, the result is a high-resolution image that mimics what a pathologist would see under a microscope when examining a skin sample removed during a traditional biopsy. By studying cell structure, a doctor can determine whether a lesion is cancerous — often right away. Images that require closer inspection can be sent electronically to specialists, a faster process than shipping specimens to laboratories.

“Patients love it,” said Dr. Jane Grant-Kels, who chairs the dermatology department at the University of Connecticut Health Center. “Patients love any technology that will give the doc more information and avoid hurting them.”

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Skin cancer is the most common form of cancer, accounting for almost half of all diagnoses in the United States, according to the American Cancer Society, with some 3.5 million new cases diagnosed each year; many more people go through biopsies that prove negative.

Grant-Kels said that in her experience, the VivaScope allows her to definitively rule out cancer two-thirds of the time, avoiding unnecessary incisions. In other cases, she will perform a traditional biopsy to check the laser reading, or excise the lesion immediately.

For now, Caliber’s optical biopsy machines are used in just a handful of top clinics and hospitals, including Brigham and Women’s Hospital and Massachusetts General Hospital. Patients generally must pay out of pocket for the tests, which cost about $150, because neither public nor private insurers cover them yet. (UConn and some others offer free laser imaging.) A biopsy is typically covered by insurance, leaving patients responsible for a co-pay.

Caliber’s chief executive, L. Michael Hone, said that the company hopes the portability and relatively low price of the VivaScope 3000 will spur wider adoption. The hand-held device, released late last year, costs $50,000 to $60,000 — about half the price of the earlier and larger VivaScope 1500.

Lasers already are widely used in medicine for procedures as diverse as removing unwanted hair and repairing corneas. Dermatologists were among the first doctors to employ lasers, using them to remove birthmarks as early as the 1960s, and they now rely on lasers to perform many surgical procedures.

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Caliber’s machines use low-power laser beams that shine through the skin and reflect off subsurface tissue, illuminating the skin cells in question. At right, a detail shot of melanoma cells from a laser image taken by machines made by Caliber Imaging.

More recently, researchers have focused on how lasers could not only replace blades in the operating room but also help with imaging and diagnostics. For example, doctors at Harvard University and the University of Michigan published a paper in September about a new laser technology that could help brain surgeons tell the difference between cancerous and healthy tissues at a microscopic level, improving their accuracy when removing tumors.

Caliber’s focus on skin biopsy mirrors the broader trend, but for the company itself it is a radical shift in business. The company was founded in 1991 in Rochester, N.Y., as Lucid Technologies; its imaging tools were primarily used to test the safety and effectiveness of topical health and beauty products made by Johnson & Johnson, Avon, Chanel, and other brands.

Lucid was rebranded as Caliber Imaging and Diagnostics last year to reflect a new direction, the company said.

And while it will continue manufacturing in Rochester, Caliber is shifting its corporate headquarters to Boston, which Hone called “the center of the universe for a lot of the medical technology and biotech industries.” He already works at an office in Post Office Square.

Commercial product testing will remain an important part of Caliber’s business, Hone said, “but is it really where there’s a broader application that can be good for humanity in general?”

“It’d be nice to do this stuff for free and say, ‘We’re just here to help,’ ” he added. “Our shareholders would probably slit my throat. But we can really make a difference and reward our investors at the same time.”